U.S. Pat. No. 6,183,414 to Wysor et al. uses a periodic vacuum pump noninvasive treatment to overcome erectile dysfunction so that after a number of treatment sessions, the patient has a natural, normal sex. Additional vacuum treatment is eventually required to maintain normal erectile function, without medications.
U.S. Pat. No. 4,738,249 to Linman et al. describes a method and apparatus for enhancing blood circulation in a predetermined portion of a patient's body, remote from the patient's heart, by distending (dilating) and relaxing arteries and veins in a vacuum chamber. Linman '249 differs from the present invention as will be described in greater detail below.
Enhanced External Counterpulsation (EECP) is described in a 2005 book, Heal Your Heart with EECP, by Dr. Debra Braverman, MD. The EECP treatment program, using cuff squeezing of legs, covers 7 weeks, causes the whole body blood flow to gradually increase so that after the 7 weeks the blood flow remains high for up to 5 years. This high blood flow provides an increased amount of oxygen and nutrients to the whole body to treat a large number of medical conditions. EECP also provides physical exercise to the muscles of each leg by squeezing.
EECP has been found effective in over 100 studies. Braverman lists medical conditions for which there is evidence of EECP effectiveness, including dementia, chronic stable angina, cardiogenic shock, congestive heart failure, during a heart attack, arthritis, atherosclerosis, heart disease, heart attack, stroke, diabetes, cardiomyopathy, cardiovascular disease, heart failure, diabetic retinopathy, chronic leg ulcers, chronic wounds, peripheral neuropathy, peripheral vascular disease, restless leg syndrome, shortness of breath, deficient sleep patterns, visual disorders, deficient thought clarity, coronary artery disease, deep vein thrombosis, depression, erectile dysfunction, athletic performance, rheumatoid arthritis, chronic infections, deficient eye blood flow, nerve injury, Parkinson's disease, hearing disorders, and tinnitus.
The known Enhanced External Counterpulsation (EECP) treatment, which is a noninvasive treatment to reduce heart workload and increase blood flow throughout the body to provide an increased amount of oxygen and nutrients to the cells and provide an increased rate of removal of cell waste products. EECP is approved by the U.S. Food and Drug Administration for chronic stable angina, cardiogenic shock, congestive heart failure, as well as during a heart attack. It is also effective in the treatment of other conditions throughout the body. EECP is described in a 2005 book, Heal Your Heart with EECP by Dr. Debra Braverman, M.D. Symptoms are eliminated or minimized for up to five years, due to increased blood flow throughout this time period. The treatment is painless and there are no adverse effects. EECP also provides passive exercise for ambulatory and non-ambulatory patients. Typically the treatment comprises thirty-five one hour sessions, one hour/day, five days/week for seven weeks.
For that Braverman EECP treatment, the patient lies on a special bed, and a therapist wraps a set of oversized blood pressure cuffs tightly around the patient's calves, lower thighs and upper thighs. An air hose connects each cuff to an air compressor. Each cuff inflates (squeezes) with air for 50 milliseconds (ms), sequentially: first the calves, then the lower thighs, then the upper thighs, and then all cuffs deflate simultaneously. It is common practice in the United States to place the known cuffs only on the legs rather than on arms and legs.
The trigger for the cuffs to inflate and deflate is the patient's heartbeat. With three stick-on electrodes on the patient's chest, a computer reads the patient's EKG (electrocardiogram) continuously throughout the treatment and uses it to synchronize the inflation and deflation of the cuffs to the patient's heart beats. When the patient's heart beats, all cuffs deflate and the heart supplies blood to the legs. When the heart rests, between beats, the cuffs inflate in sequence and squeeze the patient's legs so that blood is forced upward in the leg arteries and veins towards the heart.
This analysis of EECP is by the present inventors.
The squeezing by the three cuffs moves blood upward in the leg arteries, which causes momentary arterial dilation for two reasons. The first reason is because the closed aortic valve, during the rest period, prevents arterial blood from back-flowing into the heart, so that the blood squeezed upward by the cuffs momentarily dilates leg arteries. The second reason is that due to friction between the blood and arterial walls, the blood flow is slowed (opposed) so that momentary arterial dilation will occur above each cuff, as each cuff squeezes the arteries. It will be shown by the present inventors that arterial elasticities are increased.
When blood is forced upward in the veins, the flow is slowed (opposed) by the friction between the blood and the walls, resulting in momentary dilation of the veins. It will be shown by the present inventors that venous elasticities are increased.
During squeezing by any cuff, the blood that is forced upward will also dilate the arteries and veins located underneath the cuff. This dilation increases the elasticities of these arteries and veins. For the lower thigh cuff or upper thigh cuff, when each cuff is squeezed, sequentially, blood is blocked from moving downward by the inflated cuff below. Blood moves upward, underneath the inflated cuff, and momentarily dilates the arteries and veins under the cuff before flowing above the cuff to dilate arteries and veins, to increase vessel elasticities.
When the calf cuff inflates, blood flow at the lower end of the calf cuff is not blocked because there is not an inflated cuff below the calf cuff, so that extra blood will be forced into the arteries and veins of the foot, to increase the elasticities of these vessels. Simultaneously, blood will be forced upward, underneath the cuff, to dilate vessels underneath the cuff and vessels above the cuff, to increase vessel elasticities.
According to the present inventors, the primary reasons why EECP is effective in increasing blood flow everywhere in the body, during and after each EECP treatment session, can be explained by a finding of the present inventors, such as described in our U.S. Pat. No. 7,037,257 to Koenig et al., issued May 2, 2006, the entirety of which is and has been incorporated herein by reference.
The Wysor et al. '414 patent states that their method and apparatus treats erectile dysfunction when this condition is due to insufficient plasticity of the penile tissues. The present inventors found that Wysor's periodic vacuum pump treatment for erectile dysfunction is effective because it gradually increases the elasticity of penile arteries and veins, rather than increasing the plasticity of penile tissue, as stated in Wysor '414.